Pilots

Overview

The UCI Institute for Clinical and Translational Science (ICTS) is pleased to announce a new call for pilot applications for the ICTS Translational Science Pilot Studies Award Program. One-year awards in the amount of $40,000 will be conferred in this round.

Purpose: The ICTS Translational Science Pilot Studies Awards are intended to provide investigators with support to engage in proof-of-concept or preliminary research that addresses a common roadblock or bottleneck in translational research.  Projects are expected to inform a subsequent application for extramural funding to extend the findings, which should be generalizable across multiple diseases and lead to improved efficiency or effectiveness of future translational research.

The ICTS Translational Science Pilot Studies Award Program is supported by the National Center for Advancing Translational Sciences (NCATS), one of the centers at the National Institutes of Health (NIH). As defined by NCATS, a key tenet of translational science is to understand common causes of inefficiency and failure in translational research projects. Many of these causes are understood to be the same across targets, diseases, and therapeutic areas. In the new funding cycle for the ICTS, NCATS has mandated that Pilot Awards must address a question of translational science.  That is, Pilot Awards must be intended to be generalizable across multiple diseases and increase the efficiency and effectiveness of translational research to enhance health and reduce the burdens of illness and disability.

Examples of translational science project’s abstracts can be found here. Questions about specific ideas are welcomed.

Investigator Eligibility

• Multiple-Principal Investigator (m-PI) projects are allowed.
• At least one Principal Investigator (PI) must be full time UCI faculty or UCI community member from any school or discipline who are eligible to serve as a NIH PI.
• The individual who will be doing the majority of the work should be a named PI.
• PIs who did not receive a Pilot Studies Award from the ICTS in the prior year are eligible.
  • Investigators must take a full funding cycle break before applying again.
  • For example, if you were funded as a PI for 2023, you cannot apply as a PI again for the 2024 pilot cycle; you must wait for the following 2025 pilot cycle to apply again.

To be eligible to apply for Pilot Studies Awards, the Principal Investigator or co-Investigator MUST attend a workshop on general application preparation. Workshops are currently scheduled for July. Registration is required to attend. Zoom meeting details will follow registration. Additional workshops may be added in response to interest. 

Notes:

1. Investigators may only submit one application in which they are listed as PI or m-PI. However, a PI or m-PI can be on more than one application if he/she is listed as a co-investigator.
2. This funding opportunity is available to all investigators who meet the eligibility criteria. We especially encourage investigators from the following groups to apply:
   • Junior and mid-career faculty
   • Individuals who identify with any of the groups identified by the NIH Diversity in Extramural Programs
   • Faculty from the Children’s Hospital of Orange County (CHOC) and the Long Beach VA.
     • If CHOC and VA applicants do not have a joint UCI faculty appointment, their proposals must have a UCI m-PI.
     • All awards to CHOC and VA will occur via a subcontract; no overhead costs will be provided.

Eligible Projects and/or Project Characteristics

All characteristics must be met for it to be an eligible project:

• It must be a translational science project.
• Currently not funded.
• The project will generate preliminary results for a full application for extramural funds.
• Can be completed within a one-year funding period.
• Findings will be generalizable across a variety of diseases and improve the efficiency and speed of future translational research.
• Project must be executable without an IND or an IDE.

Application Process: Two Phase

Phase One: Pre-Application

Application Opens: July 1, 2024 (application links will be sent following attendance at a workshop)

Deadline: July 22, 2024

A pre-application is REQUIRED. Not all submitted pre-applications will advance to Phase Two for review.
The pre-application will be submitted via REDCap and must include:

• Project Title
• Amount Requested (maximum $40,000 direct costs)
• Names of Principal Investigator(s) and Co-Investigators
• Biosketch(es) for Principal Investigator(s) (New NIH format)
• Abstract (max 250 words)
  • Significance
  • Study Hypothesis/Research Question
  • Research Methods
  • Potential Impact
• Project Plan:
  • Study Hypothesis/Research Question: Briefly explain the project’s significance, aims and objectives. (max 200 words)
  • Research Methods: Address the source of the study data (humans, animals, archived samples, etc.) and provide a brief description of the study protocol: what is being done to whom, including where and by whom. (max 200 words)
  • Translational/clinical significance of the project: Explain how the results of the research could translate to a meaningful health impact. If relevant, explain how the project will reduce health inequities in the population. (max 200 words)
  • Translational Science Focus: Relevance of the proposed project to translational science.  Address the following 3 questions. (max 200 words)
    • What is the translational research roadblock your project will address?
    • How will the findings of your project be generalizable across multiple diseases?
    • How will your project lead to enhancing the efficiency and speed of future translational research?
  • Evidence of feasibility: Describe any prior experience and/or existing resources that will support your efforts to complete this research in a 12-month timeframe. (max 200 words)
• Additional Information:
  • Keywords: Please provide 3-5 keywords to best describe your study and type of expertise needed for providing a quality review.  Keywords can describe content and/or methodology.

Phase Two: Full Proposal

Application Opens: Based on scoring of pre-applications, selected applicants will be invited to submit a full proposal. Invitations will be issued on or before August 1, 2024.

Deadline: August 30, 2024

Documents and information submitted in the pre-application phase will be transferred to the full application. Please update any changes that have been made since submission.

In addition to the materials from the pre-application (updated if necessary) the application must include:

• Biosketches for co-Is (New NIH format)
• General Summary of the project written to be accessible to a general (i.e., non-academic) audience (250 words max)
• Research Plan (5 pages max, plus references) must include:
  • Specific Aims
  • Significance (be sure to address the translational science aspects of the project)
  • Innovation
  • Approach
  • Plans for applying for extramural funding
• ICTS Pilot Project Implementation Plan
• Data Management and Sharing Plan
• Home department letter of support
• Budget (itemized, 1 page maximum)
• Budget Justification (1 page maximum)
  • Funds cannot be used to support the PI’s salary, computer purchases, or travel. Other personnel salaries are allowable.
  • No overhead will be provided for outside collaborators or institutions.
  • Cost sharing is not allowed.
• Suggested Reviewers

Regulatory Approval: Please note that while having regulatory approval (IRB, IACUC) at the time of the application is not required, it MUST be in place by the funding decision for the award to be conferred. The awarded funds cannot be released by NIH mandate, until such approval has been received and NIH Prior Approval has been received.  

Resubmissions: Applications that were not funded during a prior call for ICTS pilot awards may be resubmitted a second time by checking the appropriate box during the application process. Resubmissions will have the opportunity to address the criticisms raised during the review process; however, no additional space will be allowed for the rebuttal, which will have to be included in the 5-page limit of the Research Plan. A maximum of ONE resubmission will be allowed for each previously unfunded project.

Post-Award Project Support: Before funds are released, an activation meeting will be held with the awardee, a department financial analyst, and ICTS staff at which the team will review the project implementation plan and explain the Research Acceleration and Facilitation Team (RAFT) support that will be provided to the research team. If this is a multiple-PI project, the individual who will be doing the majority of the work should be a named PI and will be participating in the scheduled RAFT calls.

Application Review Process: Pre-applications will be reviewed by an internal committee, and the full applications will be reviewed by internal, external, and community reviewers. The review criteria in both rounds will include:

• Significance and impact of the proposed research
• Qualifications of the PI and research team
• Innovation
• Approach: Scientific strength of the research design
• Scientific environment
• Overall impact
• Generalizability
• Efficiency and Speed
• Clinical/Public Health Impact
• Project feasibility within the proposed time frame
• Likelihood of generating extramural funding

The UCI ICTS participates in a national CTSA External Reviewer Exchange Consortium (CEREC) to improve fairness in the scientific review process and better match applicants with feedback from experts in their respective fields. Trained community reviewers are also included in the grant review process. In applying, you agree to allow reviewers external to UC Irvine access to your application materials. We may also share information regarding your proposal with other internal funding mechanisms to avoid funding duplicate effort and identify the best alternate funding source for your proposal.

Note: If at any point in the application process the proposal is determined to not meet the funding criterion (i.e., translational science) it will not move forward in the review process. If you are unsure your proposal fits the funding criteria, we encourage you to reach out and discuss it with us.

For more information, please contact Dr. Margaret Schneider at mls@uci.edu, Amanda Woodworth at woodwora@uci.edu, or Melissa Estrada at estradm4@uci.edu

APPLICATION DEADLINES AND SUBMISSION INSTRUCTIONS:

Pre-Application: July 22, 2024

Full Proposal (invited applicants): August 31, 2024

Submission Instructions:

• Step 1: Register and attend a workshop.
• Step 2: Following the attendance at a workshop, an individualized link to the pre-application will be sent to you. Using this link, submit a pre-application.
• Step 3: If your pre-application is chosen, submit a full proposal. A unique link to the full proposal will be sent to you with the pre-application decision notification.